Respiratory infections remain a threat to public health, as highlighted by the coronavirus disease 2019 (COVID-19) pandemic. Current threats for epidemic and pandemic spread include the viruses SARS-CoV-2 and influenza. Additionally, it is likely that novel respiratory pathogens will emerge. While most cases of SARS-CoV-2 infection and influenza are mild, progressive disease can result in hospitalisation and substantial morbidity and mortality. To improve the standard of care of patients admitted to hospital due to respiratory infections, it is critical to rapidly assess new agents and interventions.
STRIVE aims to provide an agile research platform able to investigate strategies and treatments that may improve the health of patients hospitalised with a respiratory infection. The STRIVE master protocol defines the scientific and operational structure of all trials included in the platform. The specific design and conduct of each trial are described in trial-specific appendices. This approach facilitates a rapid and flexible response with high scientific standards to support the study of new therapeutical interventions.
STRIVE is a multicentre, international, adaptive, randomised, controlled trial platform to evaluate safety and efficacy of strategies and treatments for hospitalised patients with respiratory infections. The different trials within the platform will evaluate treatments aimed at different respiratory pathogens, and multiple trials may be developed for each pathogen. Each trial will assess the safety and efficacy of an experimental agent or intervention by comparing the clinical outcome of participants against placebo. All participants will be given standard of care treatment in addition to the investigational drug or placebo and will be followed for 90-days.
The STRIVE individual trials will determine if an experimental treatment is effective in preventing disease progression and mortality related to the respiratory pathogen of interest in hospitalised patients.
STRIVE will help improve standard of care, by ensuring an agile research infrastructure, with an ability to rapidly assess interventions during epidemic transmission of one or more respiratory pathogens adversely affecting public health.
International Network for Strategic Initiatives in Global HIV Trials (INSIGHT); University of Minnesota – Clinical and Translational Science Institute – Minnesota, USA; Centre of Excellence for Health, Immunity and Infection (CHIP), Rigshospitalet, University of Copenhagen - Copenhagen, Denmark; Hennepin Medical Center - Minneapolis, Minnesota; Medical Research Council (MRC) Clinical Trials Unit at University College London (UCL) London, United Kingdom; The Institute for Clinical Research at the Veterans Affairs Medical Center - Washington, D.C., United States of America (US); Mount Sinai Medical Center, New York, New York, US; Vanderbilt University Medical Center, Nashville, Tennessee, US; US Department of Veterans Affairs.
National Institute of Allergy and Infectious Diseases (NIAID); National Institutes of Health (NIH).